Anesthesia and Critical Care Registry (ARIA)

August 5, 2025 updated by: Giovanni Landoni, Università Vita-Salute San Raffaele

Registry of Patients Undergoing Anesthesia or Intensive Care Maneuvers

In recent decades, knowledge in the anesthesiology field has increasingly expanded, allowing for the refinement of monitoring techniques, therapies, and local-regional anesthesia maneuvers, and for the extension of care to a larger number of patients, including those previously excluded due to advanced age or comorbidities. Similarly, Intensive care management has continuously evolved, following innovations in the field of drugs and with the great diffusion of extracorporeal supports. The fundamental importance of registry studies has been recognized in this context to rapidly generate reliable data and improve the quality of care.

This prospective observational study is aimed at collecting data of all patients (expected 300,000) undergoing anesthesia or intensive care maneuvers at our institution. This registry aims to assist in carrying out registry-based clinical studies focused on improving current therapeutic and patient management standards.

Study Overview

Status

Recruiting

Intervention / Treatment

Detailed Description

The study aims to collect data on 300,000 patients who undergo anesthesia and/or resuscitation procedures at the IRCCS San Raffaele Scientific Institute over a 10 years period. The information collected will include demographic data, anthropometric data, past and/or current clinical history of the patient, anamnestic clinical-instrumental data related to the anesthetic activity, data on therapeutic measures taken during stay in intensive care units, laboratory parameters, diagnostic tests, therapeutic procedures carried out during hospitalization, patient satisfaction, and evaluation scales. All this data will be anonymized prior insertion in the database, with the aim of creating a registry that can be used for scientific research. This registry aims to assist in carrying out registry-based clinical studies focused on improving current therapeutic and patient management standards. The duration of observation of each patient will be variable, depending on the length of hospital stay and/or the duration of the diagnostic-therapeutic process. The analysis will follow the clinical course of patients from admission to hospital discharge, with the possibility of conducting telephone follow-ups for certain categories of patients after 1 year. Statistical analyses will be performed by grouping or describing patients based on their characteristics or in relation to the type of anesthetic and resuscitation procedures they undergo.

This study will follow the ethical principles outlined in the Helsinki Declaration and the current regulations for Observational Studies. All patients will be fully informed about the aspects of the study and their written informed consent will be required before participation.

Participation in the study is voluntary and free. No additional costs are expected for data collection and analysis: given the observational nature of the study, insurance coverage is not required.

Study Type

Observational

Enrollment (Estimated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any patients undergoing Anesthesia or critical care -related maneuvers admitted to our hospital. All patients will follow their normal course of diagnosis/treatment without any further requirements for the scope of this study other than those provided in the normal management of patients with this condition. Furthermore, any decision regarding drug or procedure will be made by the physician based on her/his clinical judgment in the context of clinical practice, independently from the decision to include the patient in this study. No follow-up medical and/or imaging examinations/laboratory analysis after hospital discharge are needed by the present study design.

Description

Inclusion Criteria:

  • Patients undergoing Anesthesia or Critical care
  • Signed informed consent.

Exclusion Criteria:

Refused informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes of patients urdergoing anesthesia and/or critical care
Time Frame: hospital discharge (usually <=30 days)
This study will collect data on the anesthesia-related and hospital outcome of patients undergoing anesthesia and intensive care. Due to the large sample size and heterogeneity of populations, further analysis will be planned to address homogenenous subgroups of patients.
hospital discharge (usually <=30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2023

Primary Completion (Estimated)

September 1, 2033

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • ARIA - 40/INT//2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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